Roche Seeks Regulatory Approval for Skin Cancer Medicine

May 11 (Bloomberg) -- Roche Holding AG asked U.S. and
European health regulators to approve its vemurafenib drug as a
treatment for the most aggressive and deadly form of skin cancer.

Roche asked the U.S. Food and Drug Administration and the
European Medicines Agency to grant marketing permission for the
treatment as a therapy for melanoma that has spread, the Basel,
Switzerland-based company said today in an e-mailed statement.
The drugmaker also filed for approval for a diagnostic test that
would identify patients likely to benefit from the medicine.

Roche said Jan. 19 that vemurafenib, designed to treat
patients who carry a gene mutation called BRAF V600, helped them
live longer and curbed the growth of the cancer in a study. The
Swiss company is developing the medicine with Plexxikon Inc., a
U.S. biotechnology company. About 40,000 people die from
metastatic melanoma each year, according to Roche.

“We have worked swiftly to advance the vemurafenib
development program knowing that patients with metastatic
melanoma have a poor prognosis and limited treatment options,”
Hal Barron, Roche’s head of product development, said in the
statement.

Serious side effects of the medicine were a more common and
treatable skin cancer and changes in the levels of liver enzymes.
The most common side effects were rash, light sensitivity, joint
pain, hair loss and fatigue.

The number of patients with melanoma is expected to double
in developed countries to 227,000 in 2019, according to
Datamonitor Plc.